International Journal of Biomedical Materials Research

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Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs

Received: 07 March 2017    Accepted: 29 March 2017    Published: 19 June 2017
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Abstract

In this drug storage stability surveillance, we evaluated and compared the effects of different storage temperatures and ventilation conditions on the level of active pharmaceutical ingredient (API) of an ACT- based antimalarial (XYZ) drug formulation. The drug which contains artemether and lumefantrine is marketed by drug vendors in Lafia, Nasarawa state. From the analyses carried out, the concentration of lumefantrine (estimated with UV-Vis spectrophotometer) as well as Artemether (analyzed using HPLC) in the drug shows slightly different values which are statistically insignificant when investigated for the effects of storage temperatures and ventilation conditions. Drugs from pharmaceutical stores equipped with fan without cross ventilation (FNV), fan with inadequate ventilation (OCV), fan with cross ventilation (FCV) and fan with air conditioner (ACF) gave lumefantrine level of 494.30, 438.68, 472.48 and 488.68 mg respectively as against the label’s acclaimed 480 mg lumefantrine. The results for artemether includes: FNV (76.93), OCV (79.49), FCV (80.61) and ACF (73.55) milligrammes respectively as against 80 mg drug label claim. Reported values fell within the recommended (90%-120%) NAFDAC acceptable values for drug stability.

DOI 10.11648/j.ijbmr.20170503.11
Published in International Journal of Biomedical Materials Research (Volume 5, Issue 3, June 2017)
Page(s) 29-36
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

NAFDAC, ACT, Antimalarial Drug, Lumefantrine, Artemether, Amartem, Storage

References
[1] Bajaj S, Singla D, Sakhuja N. (2012). Stability testing of Pharmaceutical products, J. of Applied Pharmaceutical Science, 2(03), 129-138.
[2] Kiron SS, Shirwaikar A, Saritha M. (2011). Influence of storage conditions on the potency of amoxicillin dispersible tablets stored in hospital and community pharmacies in different regions of kerala, Asian J. Pharm Clin Res, 4 (3), 101-102.
[3] Ajayi IO, Browne EN, Bateganya F, (2008). Effectiveness of artemisininbasedcombination therapy used in the context of home management ofmalaria: a report from three study sites in sub-Saharan Africa. Malaria Journal. 27(7): 190.
[4] Roca-Feltrer A, Carneiro I & Armstrong Schellenberg JR (2008) Estimates of the burden of malaria morbidity in Africa in children under the age of 5 years. Tropical Medicine and International Health 13, 771–783.
[5] WHO (2010) WHO Guidelines for the treatment of malaria. Geneva: WorldHealth Organization.
[6] Breman JG, Alilio MS, Mills A (2004). Conquering the intolerable burden ofmalaria: what’s new, what’s needed: a summary. American Journal for Tropical Medicine and Hygiene. 71(2): 1–15.
[7] Koram KA, Abuaku B, Duah N. (2005). Comparative efficacy of antimalarialdrugs including ACTs in the treatment of uncomplicatedmalaria among children under 5 years in Ghana. Acta Tropical.95: 194–203.
[8] Malmberg M., Ngasala B., Ferreira P. E., Larsson E., Jovel I., Hjalmarsson A., Petzold M., Premji Z., Gil J. P., Bjorkman A., Martensson A. (2013). Temporal trends of molecular markers associated with artemether–lumefantrine tolerance/resistance in Bagamoyo district, Tanzania. Malar. J. 12: 103.
[9] Li, Y., Wu, Y. L., (2003). An over four millennium story behind qinghaosu (artemisinin)—a fantastic antimalarial drug from a traditional Chinese herb. Curr. Med. Chem. 10, 2197–2307
[10] AdjuikM, BabikerA, GarnerP, Olliaro P, Taylor W. (2004) International Artemisinin Study Group. Artesunate combinations fortreatment of malaria: meta-analysis. Lancet.363: 9–17.
[11] Rosenthal, P. J., McKerrow, J. H., Aikawa, M., Nagasawa, H. and Leech, J. H. (1988). A malarial cysteine proteinase is necessary for hemoglobin degradation by Plasmodium falciparum. J. Clin. Investig. 82: 1560-1566.
[12] Nayyar G., Breman J.G., Newton P.N., Herrington J. (2012). Poor-quality antimalarial drugs in Southeast Asia and sub-Saharan Africa. Lancet Infect Dis. 12: 488–496
[13] Lefevre G. (2002). PK and electrocardiographic pharmacodynamics of artemether-lumefantrine (Riamet®) with concomitant administration of ketoconazole in healthy subjects. British Journal of Clinical Pharmacology. 54: 485–492.
[14] Ballereau F, Prazuck T, Schrive I, Lafleuriel MT, Rozec D. (1997). Stability of essential drugs in the field: results of a study conducted over a two-year period in Burkina Faso. American Journal for Tropical Medicine and Hygiene. 57: 31–36.
[15] Olliaro P, Wells T. (2009). The Global Portfolio of New Antimalarial Medicines Under Development. Clinical Pharmacological Therapy.85: 584–595
[16] Bhattarai A, Ali AS, Kachur SP, Martensson A, Abbas AK (2007). Impact of artemisinin-based combination therapy and insecticide-treated nets onmalaria burden in Zanzibar. PLoS Med 4: e309.
[17] NAFDAC (2014). Standard Operating Procedure for Lumefantrine Estimation using UV-Vis Spectrophotometer. An Operation Manual of the National Agency for Food and Drug administration and Control. vol 9: 3-7
[18] Isabela D. C. and Gerson A. P. (2009). Quantitation of artemether in pharmaceutical raw material and injections by high performance liquid chromatography, Brazilian Journal of Pharmaceutical Sciences, 45, (4) : 737-742
[19] Gitua, J., Beck, A., and Rovers, J. (2014). Quality and stability of artemether-lumefantrine stored under ambient conditions in rural Mali. Abstract Malaria Journal, 13: 474
[20] Johnson CA, Stieglitz N, Schroeder ME. (2009). Opportunities and responsibilities of pharmacists on short-term medical mission teams. J Am. Pharm. Asso. 49: 801–807.
[21] Mehta AC, Hart-Davies S, Payne J, Lacey RW. (1994). Stability of amoxicillin and potassium clavulanate in co-amoxiclav oral suspension. J Clin Pharm Ter., 19(5): 313-315.
[22] Naidoo, K. K., Nompuku, P., Mkalali, S. N., Shabangu, K., Nkabinde, L., Singh, V. (2006) ‘Post-Marketing Stability Surveillance: Amoxicillin’, SA Fam Pract, 48(6): 14-14d
[23] John G, Aaron B. Rovers J (2014) Quality and stability of artemether-lumefantrine stored under ambient conditions in rural Mali. Malaria Journal, 13: 474.
[24] Shrivastava A, RIssarani, Nagori B. P. (2010). Stability Indicating High-Performance Liquid Chromatography Method for the Estimation of Artemether in Capsule Dosage Forms. J Young Pharma. 2; 2(1): 79–84.
[25] Bate R., Tren R., Hess K., and Attaran A. (2009). Physical and chemical stability of expired fixed dose combination artemether-lumefantrine in uncontrolled tropical conditions. Malaria Journal, 8: 33.
[26] Arun, R. and Smith, A. (2011). Development of Analytical Method for Lumefantrine by UV Spectrophotometry International Journal Research Pharmaceutical Sciences 1 (3): 321-324.
[27] Amusan, V. O., Yahaya A. U., Philip A. V. (2017). Knowledge, Attitudes and Practices on Malaria Prevention and Control Among Private Security Guards Within Kaduna Metropolis, Kaduna State-Nigeria. Science Journal of Public Health. 5 (3): 240-245
[28] GUP I, Orji U. N., Amadi A. (2013). Malaria Morbidity among Under-Five Nigerian Children: A Study of its Prevalence and Health Practices of Primary Care Givers (Mothers) in a Resource-Poor Setting of a Rural Hospital in Eastern Nigeria. European Journal of Preventive Medicine. 1(3): 50-57.
Author Information
  • Department of Chemistry, College of Sciences, Federal University of Agriculture, Makurdi, Nigeria

  • Department of Chemistry, College of Sciences, Federal University of Agriculture, Makurdi, Nigeria; Department of Food Safety and Applied Nutrition, National Agency for Food and Drug Administration and Control, Lafia, Nigeria

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    Adams Udoji Itodo, Idriss Emmanuel. (2017). Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs. International Journal of Biomedical Materials Research, 5(3), 29-36. https://doi.org/10.11648/j.ijbmr.20170503.11

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    ACS Style

    Adams Udoji Itodo; Idriss Emmanuel. Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs. Int. J. Biomed. Mater. Res. 2017, 5(3), 29-36. doi: 10.11648/j.ijbmr.20170503.11

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    AMA Style

    Adams Udoji Itodo, Idriss Emmanuel. Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs. Int J Biomed Mater Res. 2017;5(3):29-36. doi: 10.11648/j.ijbmr.20170503.11

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  • @article{10.11648/j.ijbmr.20170503.11,
      author = {Adams Udoji Itodo and Idriss Emmanuel},
      title = {Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs},
      journal = {International Journal of Biomedical Materials Research},
      volume = {5},
      number = {3},
      pages = {29-36},
      doi = {10.11648/j.ijbmr.20170503.11},
      url = {https://doi.org/10.11648/j.ijbmr.20170503.11},
      eprint = {https://download.sciencepg.com/pdf/10.11648.j.ijbmr.20170503.11},
      abstract = {In this drug storage stability surveillance, we evaluated and compared the effects of different storage temperatures and ventilation conditions on the level of active pharmaceutical ingredient (API) of an ACT- based antimalarial (XYZ) drug formulation. The drug which contains artemether and lumefantrine is marketed by drug vendors in Lafia, Nasarawa state. From the analyses carried out, the concentration of lumefantrine (estimated with UV-Vis spectrophotometer) as well as Artemether (analyzed using HPLC) in the drug shows slightly different values which are statistically insignificant when investigated for the effects of storage temperatures and ventilation conditions. Drugs from pharmaceutical stores equipped with fan without cross ventilation (FNV), fan with inadequate ventilation (OCV), fan with cross ventilation (FCV) and fan with air conditioner (ACF) gave lumefantrine level of 494.30, 438.68, 472.48 and 488.68 mg respectively as against the label’s acclaimed 480 mg lumefantrine. The results for artemether includes: FNV (76.93), OCV (79.49), FCV (80.61) and ACF (73.55) milligrammes respectively as against 80 mg drug label claim. Reported values fell within the recommended (90%-120%) NAFDAC acceptable values for drug stability.},
     year = {2017}
    }
    

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    T1  - Degradation Study on the Effects of Storage Conditions on Active Ingredient of an ACT- Based Anti-malarial Drugs
    AU  - Adams Udoji Itodo
    AU  - Idriss Emmanuel
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    DO  - 10.11648/j.ijbmr.20170503.11
    T2  - International Journal of Biomedical Materials Research
    JF  - International Journal of Biomedical Materials Research
    JO  - International Journal of Biomedical Materials Research
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    PB  - Science Publishing Group
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    UR  - https://doi.org/10.11648/j.ijbmr.20170503.11
    AB  - In this drug storage stability surveillance, we evaluated and compared the effects of different storage temperatures and ventilation conditions on the level of active pharmaceutical ingredient (API) of an ACT- based antimalarial (XYZ) drug formulation. The drug which contains artemether and lumefantrine is marketed by drug vendors in Lafia, Nasarawa state. From the analyses carried out, the concentration of lumefantrine (estimated with UV-Vis spectrophotometer) as well as Artemether (analyzed using HPLC) in the drug shows slightly different values which are statistically insignificant when investigated for the effects of storage temperatures and ventilation conditions. Drugs from pharmaceutical stores equipped with fan without cross ventilation (FNV), fan with inadequate ventilation (OCV), fan with cross ventilation (FCV) and fan with air conditioner (ACF) gave lumefantrine level of 494.30, 438.68, 472.48 and 488.68 mg respectively as against the label’s acclaimed 480 mg lumefantrine. The results for artemether includes: FNV (76.93), OCV (79.49), FCV (80.61) and ACF (73.55) milligrammes respectively as against 80 mg drug label claim. Reported values fell within the recommended (90%-120%) NAFDAC acceptable values for drug stability.
    VL  - 5
    IS  - 3
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